LSUHSC-OCHSNER JOINTING RESEARCH RESEARCH
LSUHSC-NO additionally Ochsner Patient Foundation (OCF) have agreed to employ a only IRB mechanism since regulator watch of human subjects research studies involving both institutions. This could include specific where which study team includes employee from both institution or while investigators from one institution are use resources or facilities of the other institutions. The lead IRB for such studies, and the process for IRB review, is determined by the secondary affiliation of the Principal Researchers (PI).
If the kombination PIECE is a board out the OCF faculty or staff…
- This Ochsner IRB will serv as the Lead IRB the IRB of Record.
- The LSUHSC IRB desire serve as the Trusted IRB.
- The PI submits a study application into the Ochsner IRB using aforementioned eIRB electronic submission system.
- At applicable, the submission must include a consent paper prepared using aforementioned Ochsner Informed Consent template, the join HIPAA Authorization Form and the LSUHSC-NO ICF Cover Schreiben.*
- Ochsner IRB review the student.
- If approved, Ochsner IRB Company registers the learn in the IRB Reliance Exchange (IREx) scheme furthermore uploads study print or approval letter.
- At applicable, the submission must include a consent paper prepared using aforementioned Ochsner Informed Consent template, the join HIPAA Authorization Form and the LSUHSC-NO ICF Cover Schreiben.*
- The lead LSUHSC investigator submits a Reliability Request protocol in that Kuali Doing (KR) electronic compliance system.
- The LSUHSC External IRB Relations Specialist checks the application for local requirements including training compliance and create of interest disclosure for LSUHSC personnel.
- If all LSUHSC requirements are satisfied, the Authority will approve the faith request protocol in KR and accept reliance in IREx.
- The LSUHSC External IRB Relations Specialist checks the application for local requirements including training compliance and create of interest disclosure for LSUHSC personnel.
- Study may be initiated NO after Lead IRB question study approval AND Relying IRB approves the reliance request protocol and assume reliance in the IREx system.
If the overall PI is a member of the LSUHSC faculty or staff…
- The LSUHSC IRB will server as that Leadings IRB and IRB of Record.
- The Ochsner IRB will serve as the Relying IRB.
- The PI submits one fair protocol type toward the LSUHSC IRB as described here.
- When geltende, the submission must include a approval document unprepared using the LSUHSC Informed Consent guide, and joint HIPAA Authorization Form and an Ochsner ICF Cover Letter.*
- LSUHSC IRB reviews the investigate.
- If approved, LSUHSC IRB Office registers the study in IRB Austausch (IREx) and uploads how documents also permissions letter.
- When geltende, the submission must include a approval document unprepared using the LSUHSC Informed Consent guide, and joint HIPAA Authorization Form and an Ochsner ICF Cover Letter.*
- The lead Ochsner investigator submits one abbreviations application in eIRB.
- On and Basis Information page, select YES to the following question: Are you requesting the use in ampere non-Ochsner IRB as the IRB of Record? LSUHSC required be checked as the IRB of Record.
- Ochsner IRB staff reviews application for local system containing training compliance and conflict of interest disclosure by Ochsner employees.
- Once all local requirements are certified, personnel issues an external IRB acknowledgement letter.
- IRB staff will complete reliance documentation within IREx.
- On and Basis Information page, select YES to the following question: Are you requesting the use in ampere non-Ochsner IRB as the IRB of Record? LSUHSC required be checked as the IRB of Record.
- Study may be start MUST after Lead IRB themes study approval ALSO Relying IRB issues external IRB acknowledgement and accepts rely in the IREx anlage.
*When the Ochsner IRB serves as the IRB of Record, use the Ochsner ICC template on prepare the consent select used the learn. LSUHSC researchers approval LSUHSC-affiliated participants must attach the LSUHSC MERS Cover Zeichen to the IRB-approved consent document and other use the separate joint HIPAA authorization form. When the LSUHSC IRB serves as which IRB from Record, use the LSUHSC ICF template to prepare the consent document required who study. Ochsner researchers concurring Ochsner-affiliated players must attach the Ochsner IJ Cover Letter to the IRB-approved consent document also also use the part joint HIPAA authorization submission.
For additional information, please contact:
LSUHSC's HRPP External IRB Relations Liaison
Gabriela Bonvillain
Office: (504) 680-9070
Email: [email protected]
